Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease

NCT01637012 | Completed Phase 4

• 1 other identifier: 2.0, 2011-12-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Conditions

Stable Angina; Unstable Angina; Myocardial Infarction

Keywords

ALEX; coronary stent; cobalt-chromium; sirolimus; OCT

Outcome Measures

Primary Outcomes (3)

• Assessment of stent strut coverage and parameters of restenosis

  Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 12 months follow-up after the baseline procedure in group of first 20 patients

  at 12 months follow-up

• Assessment of stent strut coverage and parameters of restenosis

  Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 6 months follow-up after the baseline procedure in group of second 20 patients

  at 6 months follow-up

• Assessment of stent strut coverage and parameters of restenosis

  Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients

  at 3 months follow-up

Secondary Outcomes (5)

• Procedural success

  during index hospitalization

• Occurrence of stent thrombosis

  at 30 days follow-up

• Occurrence of stent thrombosis

  at 12 months follow-up

• Incidence of Major Adverse Cardiac Events

  at 30 days follow-up

• Incidence of Major Adverse Cardiac Events

  at 12 months follow-up

Study Arms (1)

ALEX stent arm

EXPERIMENTAL

implantation of ALEX stent during index procedure

Procedure: Implantation

Interventions

Implantation PROCEDURE

index angioplasty with ALEX stent implatation

Also known as: ALEX Stent

ALEX stent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee
• clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels
• earlier effective supply of others lesions in others vessels in case of multivessels disease
• female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment
• target lesion stentosis must be \> 70% (visual estimate)
• Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)

You may not qualify if:

• anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
• acute or chronic renal failure (serum creatinine \> 2 mg%, GFR \< 60 ml/min/1.73m2)
• left ventricular ejection fraction (LVEF) \< 40%
• cardiogenic shock
• short life expectancy (\< 1 year)
• any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
• current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints
• chronic total occlusion
• calcified lesion which cannot be successfully dilated
• location of lesions in the winding vessels where there is no possibility of OCT imaging
• target stenosis located in venous or arterial bridge
• unprotected left main coronary disease with \> 50% stenosis

Sponsors & Collaborators

• Balton Sp.zo.o.: lead
• KCRI: collaborator

Study Sites (5)

Carint Scanmed Szpital Sw. Rafala

Krakow, Bochenka 12, 30-693, Poland

Location

Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii

Krakow, Kopernika 17, 31-501, Poland

Location

Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny

Ustroń, Sanatoryjna 7, 43-450, Poland

Location

Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

Dąbrowa Górnicza, Szpitalna 13, 43-300, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej

Warsaw, Woloska 137, 02-507, Poland

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Myocardial Infarction

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jacek Legutko, MD, PhD

  Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland

  PRINCIPAL INVESTIGATOR

• Dariusz Dudek, Prof.

  Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

PL (5)